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NCT01248286 · ClinicalTrials.gov registry record · NA
Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT01248286 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 100 participants.
The verdict
NCT01248286, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
Food products derived from cereal grains constitute a major part of the daily diet of many Americans . For example, a typical Chinese American eats rice about 9.5 times a week on an average. However, most of these foods are derived from refined grain. During the refining process grains are stripped of their bran and germ which results in depletion of several biologically active constituents including fiber, anti-oxidants, phytoestrogens and minerals. From observational studies there is evidence for a protective effect of whole-grain foods with regard to the development of type 2 diabetes. More recently, higher intake of whole grains was also associated with decreases in insulin resistance - a risk factor related to the development of type 2 diabetes. In this randomized study the investigators plan to replicate this beneficial effect of improving insulin sensitivity in patients with pre-diabetes and go a step further by exploring the potential mechanisms by which this benefit may occur. The investigators will assess the effect of consuming a whole-grain-rich diet on levels of advanced glycation endproducts (AGE), RAGE (receptor for AGE) and markers of inflammation and oxidative stress - all of which have been shown to play an important role in the pathogenesis of diabetes mellitus. The investigators will also look for correlations between the levels of these markers with insulin sensitivity to identify potential mechanisms of pathogenesis.
Interventions
- OTHER Whole grain rice
- OTHER Refined grain rice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01248286
The ClinicalTrials.gov registry entry for NCT01248286 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Whole grain rice is the first listed.
NCT01248286 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01248286 about?
NCT01248286 is a clinical study titled "Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes". Food products derived from cereal grains constitute a major part of the daily diet of many Americans . For example, a typical Chinese American eats rice about 9.5 times a week on an average. However, most of these foods are derived from refined grain. During the refining process grains are stripped ...
What is the current status of trial NCT01248286?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2010-11. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01248286?
The interventions under investigation include: Whole grain rice (OTHER), Refined grain rice (OTHER).
Who is sponsoring clinical trial NCT01248286?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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